BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3854223 · Received June 6, 2014

    Report

    Report Number
    1416980-2014-18220
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) H13K06034 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. AS THE DEVICE WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED TWO DAYS AFTER THE ONSET OF PERITONITIS. THE PATIENT WAS TREATED WITH 2G OF INTRAVENOUS CEFTRIAXONE (FREQUENCY NOT REPORTED) AND ORAL VANCOMYCIN (DOSE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. ON AN UNKNOWN DATE IN THE SAME MONTH, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333076 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R FLEXICAP| DIANEAL PD4 AMBUFLEX| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE| MINICAP